Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03780608
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2018-12-18
Brief Title:
This Study is a Phase II Study of AZD6738 in Combination With Durvalumab in Patients With Solid Tumor Cohort A N30 GC Who Have Failed Secondary Chemotherapy Treatments Regimen Cohort B B30 Melanoma Patients Who Have Failed to IO
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Phase II Study of AZD6738 in Combination With Durvalumab MEDI4736 in Patients With Metastatic Solid Tumor as Salvage Treatment
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a phase II study of AZD6738 in combination with durvalumab in patients with solid tumor cohort A N30 GC who have failed secondary chemotherapy treatments regimen cohort B B30 melanoma patients who have failed to IO Patients will receive AZD6738 plus durvalumab combination regimen
AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 lead-in period and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1
Tumour evaluation using modified RECIST 11 will be conducted at screening within 28 days prior to first dose and every 8 weeks relative to the date of first dose up to week 40 then every 12 weeks until objective disease progression within a window of - 7 days of the scheduled date
Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit as judged by the investigator and secure supply of medication Upon confirmation of objective disease progression or treatment disconiutation criteria are met both durvalumab and AZD6738 must be discontinued Patients may continue with AZD6738durvalumab beyond objective disease progression determined by modified RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If either durvalumab andor AZD6738 are deemed intolerable as judged by the investigator so that discontinuation of either agent is deemed in the patients best interest despite dose interruptions dose modification and initiation of supportive treatments both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study Patients are not permitted to continue either AZD6738 or durvalumab as monotherapy There is no maximum duration of treatment with AZD6738 and durvalumab
The imaging modalities used for modified RECIST 11 assessment will be CT or MRI scans of chestabdomen and pelvis modified RECIST 11 scans will be analysed by the investigator on site
Patients will also be requested to provide tumour samples from the primary or metastatic tumours pre-study and on progression Sample provision is mandatory subject to aspecific consent and will aid understanding of resistance mechanisms However if biopsy site is not feasible the protocol will allow waiving the rebiopsy procedure
AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 lead-in period and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1
Tumour evaluation using modified RECIST 11 will be conducted at screening within 28 days prior to first dose and every 8 weeks relative to the date of first dose up to week 40 then every 12 weeks until objective disease progression within a window of - 7 days of the scheduled date
Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit as judged by the investigator and secure supply of medication Upon confirmation of objective disease progression or treatment disconiutation criteria are met both durvalumab and AZD6738 must be discontinued Patients may continue with AZD6738durvalumab beyond objective disease progression determined by modified RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If either durvalumab andor AZD6738 are deemed intolerable as judged by the investigator so that discontinuation of either agent is deemed in the patients best interest despite dose interruptions dose modification and initiation of supportive treatments both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study Patients are not permitted to continue either AZD6738 or durvalumab as monotherapy There is no maximum duration of treatment with AZD6738 and durvalumab
The imaging modalities used for modified RECIST 11 assessment will be CT or MRI scans of chestabdomen and pelvis modified RECIST 11 scans will be analysed by the investigator on site
Patients will also be requested to provide tumour samples from the primary or metastatic tumours pre-study and on progression Sample provision is mandatory subject to aspecific consent and will aid understanding of resistance mechanisms However if biopsy site is not feasible the protocol will allow waiving the rebiopsy procedure
Detailed Description:
Target subject population
There will be two cohorts for this study
Cohort A Patients with refractory gastric cancer who have failed secondary chemotherapy treatments for advanced disease will be enrolled Patients must have imaging confirmed progression on previous chemotherapy for gastric cancer treatment with at least one measurable lesion per modified RECIST 11 GC patients must not have received previous therapy with immune checkpoint inhibitors Prior exposure to AZD6738 is not allowed
Cohort B Patients with metastatic melanoma patients who have failed prior anti-PDL1 will be enrolled Anti-PDL1 therapy should be the immediate prior regimen before study entry
Duration of treatment Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit as judged by the investigator and secure supply of medication Upon confirmation of objective disease progression or treatment disconiutation criteria are met both durvalumab and AZD6738 must be discontinued Patients may continue with AZD6738durvalumab beyond objective disease progression determined by RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If either durvalumab andor AZD6738 are deemed intolerable as judged by the investigator so that discontinuation of either agent is deemed in the patients best interest despite dose interruptions dose modification and initiation of supportive treatments both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study Pateints are not permitted to continue either AZD6738 or durvalumab as monotherapy There is no maximum duration of treatment with AZD6738 and durvalumab
There will be two cohorts for this study
Cohort A Patients with refractory gastric cancer who have failed secondary chemotherapy treatments for advanced disease will be enrolled Patients must have imaging confirmed progression on previous chemotherapy for gastric cancer treatment with at least one measurable lesion per modified RECIST 11 GC patients must not have received previous therapy with immune checkpoint inhibitors Prior exposure to AZD6738 is not allowed
Cohort B Patients with metastatic melanoma patients who have failed prior anti-PDL1 will be enrolled Anti-PDL1 therapy should be the immediate prior regimen before study entry
Duration of treatment Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit as judged by the investigator and secure supply of medication Upon confirmation of objective disease progression or treatment disconiutation criteria are met both durvalumab and AZD6738 must be discontinued Patients may continue with AZD6738durvalumab beyond objective disease progression determined by RECIST 11 at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria
If either durvalumab andor AZD6738 are deemed intolerable as judged by the investigator so that discontinuation of either agent is deemed in the patients best interest despite dose interruptions dose modification and initiation of supportive treatments both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study Pateints are not permitted to continue either AZD6738 or durvalumab as monotherapy There is no maximum duration of treatment with AZD6738 and durvalumab
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None